A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dablGatran etexilate in patients after heart valve replacemeNt (RE-ALIGN)
- van der Werf, F
- Brueckmann, M
- Connolly, SJ
- Friedman, J
- Granger, CB
- Hartter, S
- Harper, R
- Kappetein, Arie-Pieter
- Lehr, T
- Mack, MJ
- Noack, H
- Eikelboom, JW
DOIAbstract
Background Vitamin K antagonists are the only oral anticoagulants approved for long-term treatment of patients with a cardiac valve replacement. Objective This study aims to test a new dosing regimen for dabigatran etexilate in patients with a mechanical bileaflet valve. Methods Patients aged >= 18 years and 3 months before randomization, will be randomized between dabigatran etexilate or warfarin (in a ratio of 2:1) in an open-label design. Initial doses of dabigatran will be based on the estimated creatinine clearance, and the doses will be adjusted based on measuring Conclusions RE-ALIGN is the first study to test an alternative to warfarin in patients with mechanical heart valves. A definitive phase III study will be planned based on th...